Basic Chemical Information
1. Standard Chinese name: New Listat, also known as Silistat or Sitilista
2. English name: Cetilistat, R&D code ATL-962
3. CAS number: 282526-98-1
4. Chemical full name: 2-Hexadecyloxy-6-methyl-4H-3,1-benzoxazin-4-one
5. Molecular formula: \ (\ boldsymbol {C_ {25}H_{39}NO_3 }\)
6. Molecular weight: 401.58
7. Appearance: White to off white crystalline powder
8. Melting point reference: 72-76 ℃
9. Solubility characteristics: Almost insoluble in water, soluble in DMSO and chloroform, slightly soluble in ethyl acetate
10. Product classification: Reversible gastrointestinal lipase inhibitors, candidate drug materials for anti obesity
11. Characteristics of action: It mainly works locally in the intestine, almost not absorbed into the bloodstream, and does not affect the central nervous system
12. Conventional purity: Refined raw materials ≥ 98.0%, high-purity grade can reach above 99.0% (HPLC detection)
13. Recommended storage: Sealed, cool, dry, and dark storage. Long term storage is recommended to be refrigerated at 2-8 ℃
14. Conventional packaging: sample aluminum foil vacuum bag; Bulk commonly used 25kg cardboard drum, with double-layer PE sealed inner lining bag inside
15. Detection method: HPLC-DAD is used for content and related substance detection, LC-MS is used for qualitative confirmation
16. Regulatory Explanation: Materials are only for scientific research and experimental use
Pharmacological mechanism of action
Xinlisitaka is a reversible gastrointestinal lipase inhibitor with a mechanism of action similar to orlistat. It mainly works locally in the digestive tract, inhibiting the activity of gastric lipase and pancreatic lipase, hindering the breakdown and absorption of dietary triglycerides, reducing fat intake, and achieving weight control; Compared to orlistat, some clinical studies suggest that the adverse reactions of gastrointestinal oil excretion are relatively milder.
Purity and Quality Control of Xinlisitaka
As a research grade weight reducing active raw material, Xinlishi has a complete and rigorous purity system and quality control standards. It follows the pharmacopoeia general rules and ICH quality control guidance principles throughout the process, from raw material synthesis, refining and purification to finished product outbound, ensuring stable indicators, purity standards, and controllable impurities for each batch of products. It is suitable for various scientific research experiments, testing and development, and formula debugging scenarios. The mainstream purity of this product is divided into two levels. The purity of conventional refined raw materials is ≥ 98.0% (HPLC liquid phase detection), and the purity of high-purity refined raw materials can reach over 99.0%. The purity of high-quality products is stably maintained at 99.5%. All purity data are accurately detected by high-performance liquid chromatography area normalization method. The linearity, separation degree, and tailing factor all meet the system applicability requirements, and the detection data is true and traceable.
In terms of impurity control, our company implements strict internal control standards to strictly control various organic and inorganic impurities. The limit of a single unknown impurity is ≤ 0.10%, and the process related impurities are strictly controlled. The total impurity content is ≤ 0.5%, effectively avoiding the accumulation of impurities that may affect experimental data and product stability. At the same time, strictly control the drying weight loss index, control it to ≤ 0.5%, and prevent the raw materials from absorbing moisture and lowering the effective content due to excessive moisture content; Burning residue ≤ 0.1%, strictly control inorganic impurities such as inorganic salts and metal residues. The total content of heavy metals is strictly controlled within 10ppm, which meets the safety and quality control requirements of scientific research raw materials and eliminates the problem of excessive heavy metals.
The complete set of quality control testing items is standardized and includes core indicators such as appearance, melting point identification, purity content, related substances, moisture drying loss, ignition residue, heavy metals, solubility, and crystal consistency. Each batch of products can be issued with a formal COA quality inspection report. HPLC-DAD is used as the core quantitative method for detection, combined with LC-MS/MS for impurity qualitative confirmation, to accurately identify trace unknown impurities and ensure the accuracy and reliability of detection results. The raw materials are strictly sealed in the dark and stored in a low-temperature dry manner, effectively avoiding degradation and deterioration caused by high temperature, light, and humidity, and eliminating the problems of purity degradation and impurity increase. All batches have uniform quality, small batch differences, stable and controllable quality, fully meeting the high standard usage requirements for scientific research experiments, analysis and testing, and formula development.
New Listat packaging method
1. The raw materials of Xinli Sita are packaged in moisture-proof, light proof, and sealed special packaging throughout the process, effectively preventing the powder from absorbing moisture, oxidizing, and degrading, and ensuring the stability of the raw materials.
2. The sample specifications are uniformly sealed in vacuum aluminum foil bags, which are clean, sterile, and have strong sealing properties, suitable for experimental testing.
3. For small batches of 1kg and 5kg, double-layer PE inner bags and outer aluminum foil thickened sealed packaging are used to lock moisture, dust, and prevent leakage.
4. Bulk 25kg standard industrial equipment uses thick cowhide cardboard drums, which are sturdy and pressure resistant, suitable for long-distance transportation and long-term storage.
5. The barrel is equipped with * * double-layer thick polyethylene inner lining bags, double sealed with zip ties, to isolate air and moisture.
6. All packaging is brand new, residue free, and clean, with no impurities or secondary packaging contamination, ensuring the purity of the materials.
7. Clear standard information should be printed on the outer packaging, including product name, CAS number, batch number, net weight, production date, shelf life, and storage conditions.
8. Support personalized packaging customization, and can customize different specifications of packaging according to customer needs.
9. The export order adopts export specific reinforced packaging, which is anti-collision, pressure resistant, moisture-proof, and suitable for international long-distance logistics.
10. High purity premium raw materials can be packaged in light resistant and heat-insulating packaging to prevent component degradation and discoloration caused by light exposure.
11. All packaging specifications are consistent, batch specifications are standardized, sample and bulk packaging standards are consistent, and quality is consistent.
12. Before shipment, conduct a unified re inspection of the sealing, appearance, and sealing to ensure that there is no damage, air leakage, or powder leakage, and to guarantee the integrity of the goods upon arrival.
New Lishi Shipping Logistics
1. Samples and small batch goods can be shipped by DHL, FedEx, UPS international commercial express, door-to-door delivery, stable delivery time, suitable for scientific research sample delivery.
2. International air freight can be arranged for small and medium-sized orders, with advance locking of air cargo space and supporting protective packaging to ensure the stability of material transportation.
3. For large quantities of goods, sea freight containers are preferred for transportation, and two options are available: regular dry containers and constant temperature refrigerated containers.
4. For shipments to Russia and Central Asia, the China Europe freight train can be used for cross-border railway transportation with minimal transit, making it suitable for delivery to inland countries.
5. Southeast Asian neighboring countries can arrange cross-border land transport dedicated lines to reduce the risk of transit damage and control transportation costs.
6. Can undertake various international trade transaction terms such as FOB, CIF, CFR, DDP, DDU, etc., and cooperate with customers' foreign trade mode operations.
7. Assist in organizing a complete set of customs declaration documents, standardize and truthfully declare product information, and complete the domestic export declaration process.
8. The shipment is accompanied by commercial invoices, packing lists, COA quality inspection reports, MSDS safety technical manuals to meet the requirements of customs clearance.
9. Assist in processing certificates of origin and other documents according to customer needs to facilitate smooth customs clearance in the destination country.
10. The raw materials are packaged in light and moisture resistant sealed packaging, and when temperature control is required, insulated containers and temperature recorders are equipped for full monitoring.
11. We can handle international freight insurance to avoid potential shipping risks such as moisture, damage, and lost items during transportation.
12. After the goods are shipped, provide the logistics waybill in a timely manner, and assign a dedicated person to follow up on the logistics dynamics and synchronize transportation node information throughout the process.
13. The outer packaging mark and label content can be adjusted according to the requirements of the destination country's customs to comply with local inspection standards.
14. Coordinate with customers in advance, cooperate to improve relevant documentation for destination country registration, and minimize customs clearance delays as much as possible.
15. All export operations strictly comply with the relevant laws and regulations of China's customs and the destination country's import and export, and are shipped in compliance.
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